Events

Device Recall HamiltonG5 Ventilator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hamilton Medical Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    58014
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1928-2011
  • 사례 시작날짜
    2011-02-16
  • 사례 출판 날짜
    2011-04-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97973
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Facility Use Continuous Ventilator - Product Code CBK
  • 원인
    The adaptive volume/pressure regulation can be automatically and permanently reduced to peep + 3 mbar when a closed suctioning maneuver is performed on the patient and may be undetected by the operator.
  • 조치
    A Medical device Safety Alert and Corrective Action along with a cover letter, was sent to all locations on February 16, 2011. The letter identified the affected product along with the reason for recall. The letter states that operators deactivate the "high tidal volume" alarm as described in appendix K.4 of the operator's manual until the ventilator is upgraded with a corrected software. Distributors will upgrade the affected devices with the corrected software as soon as possible. Questions can be directed to 800-426-6331, ext 215.

Device

Device Recall HamiltonG5 Ventilator
  • 모델명 / 제조번호(시리얼번호)
    Software version V2.00x and Neonatal Option or V2.01x and Neonatal software
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- MA, FL, GA, NC, MI, NC, MO, TX, and WV.
  • 제품 설명
    Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or V2.01x and Neonatal software. Hamilton-G5: catalog number 159001; || Neonatal Software catalog number: 159700; Neonatal Option catalog number: 159187. Hamilton Medical || Intended for use in the hospital and institutional environment where healthcare professionals provide patient care.
  • Manufacturer
    Hamilton Medical Inc

Manufacturer

Hamilton Medical Inc
  • 제조사 주소
    Hamilton Medical Inc, 4990 Energy Way, P O Box 30008, Reno NV 89502-3008
  • 제조사 모회사 (2017)
    Hamilton Bonaduz Ag
  • Source
    USFDA